Tag Archives: gout

August, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced DUZALLO was approved by the U.S. Food and Drug Administration (FDA) as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. …

April, 2016

26 April 2016 AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment …

December, 2015

22 December 2015 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved ZURAMPIC® (lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an …

November, 2015

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive subanalysis data of the Phase III lesinurad studies (CLEAR1, CLEAR2 and CRYSTAL) for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).The results demonstrated a consistent efficacy and safety profile in patients with normal renal function, as well …

January, 2015

The European Medicines Agency (EMA) has accepted AstraZeneca’s marketing authorization application for its investigational gout drug, which the company acquired through its acquisition of Ardea Biosciences. AstraZeneca said that the EMA accepted its application for lesinurad 200mg tablets for the chronic treatment of hyperuricaemia in gout patients. Lesinurad is a …